A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen R... | Stopped
A Study of Galeterone Compared to E... | Stopped
A Study of Galeterone Compared to Enzalutamide In Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic CRPC
ARMOR3-SV

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Medical Conditions
  • Prostate Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Stopped
Trial source and source ID number
NCT02438007
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Galeterone, Drug : Enzalutamide

Study Arm Groups : Galeterone, Enzalutamide

Intervention Type
See Interventions above
Primary Outcome Measures
    Radiographic Progression-free survival; ≥ 8 months
Secondary Outcome Measures
    Overall Survival; ≥ 8 months; Time to Initiation of Cytotoxic Chemotherapy; ≥ 8 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Male
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    Inclusion Criteria:

    - Progressive metastatic (M1) disease on androgen deprivation therapy

    - Detectable AR-V7 from circulating tumors (CTCs)

    - ECOG performance status 0 or 1

    Exclusion Criteria:

    - Prior treatment with second generation anti-androgens (e.g. abiraterone, enzalutamide)

    - Prior treatment with chemotherapy for CRPC
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Southampton General Hospital
Southampton
England
SO16 6YD
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
Guy's Hospital
London
SE1 9RT
Truro
TR1 3LJ
Brighton
BN2 5BE
Sutton
SM2 5PT
Glasgow
G12 0YN
Postgraduate Medical School, University of Surrey
Guildford
GU2 7WG
University Hospitals Birmingham
Birmingham
England
B15 2PR
University College of London Hospitals
London
England
NWI 2PG
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Australia, Belgium, Canada, France, Italy, Spain, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
ARMOR3-SV
Sponsor(s)
Novus Therapeutics, Inc
Key Dates

Recruitment Start Date

Jun 2015

Recruitment End Date

Jul 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

19 Mar 2015

Date updated in source

21 Sep 2017